Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.

FDA device recall Z-2602-2025 · posted 2025-09-19 · Open, Classified

Recall details

Recalling firm

Philips North America Llc

Reason for recall

The patient support table (couch) may descend unexpectedly to the lowermost position due to a component (ball screw) misalignment after a replacement.

Action taken

Philips Medical notified consignees on about 08/11/2025 via letter. Consignees were instructed that they could continue using the affected systems accordance with the intended use and by following the recommendation: Observe the warning listed in Instructions for Use (IFU) and make sure that the patient is strapped securely to avoid dangling of the hands. Ensure that the patient is placed securely on the patient table and is not in danger of falling. Additionally, consignees were instructed to complete and return the provided response form, to circulate Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue and retain this letter with your system(s) until your system is inspected and corrected if necessary. Philips will contact consignees to schedule a time for a Philips Field Service Engineer (FSE) to visit each site and to inspect the affected system (FCO 72800832) and correct the system if necessary (FCO 72800833).

Root cause

Process control

Status

Open, Classified

Product code

JAK

Quantity affected

24 units

Distribution

Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, Hu

Date initiated

2025-08-13

Date posted

2025-09-19

Location

Cambridge, MA

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